UPDATE 2-Ipsen/Medicis Botox rival Dysport clears FDA hurdle
* Approved as an anti-wrinkle treatment
* Approved to treat cervical dystonia
* Ipsen to launch Dysport for cervical dystonia in H2
* Medicis to launch Dysport for aesthetic use in 30-60 days
* Ipsen shares up 7 percent
(Adds details, analyst comments)
April 30 (Reuters) - Medicis Pharmaceutical Corp (MRX.N) and Ipsen (IPN.PA) said their drug Dysport was approved by U.S. health regulators as an anti-wrinkle treatment and for cervical dystonia, or spasms of the neck muscles, earlier than expected.
The news sent shares of the French drug maker up 8.5 percent after the announcement. Ipsen shares were trading up more than 7 percent at 31.57 euros at 0907 GMT.
"The approval and cautious labelling of Dysport is in line with our expectations and supports our Overweight rating," Morgan Stanley analyst Paul Mann, who covers Ipsen, said in a note.
The U.S. Food and Drug Admnistration was originally scheduled to rule on the marketing application for the aesthetic use of drug in mid-April.
But the companies were still involved in discussions at the time regarding the labelling and detail of any possible side-effects with the regulator, leading to fears about a potential delay in approval.
Several analysts had expected the approval of the drug as an anti-wrinkle treatment to come in the second half of this year.
Ipsen said last year it hoped to get the U.S. marketing go-ahead for Dysport in cervical dystonia by mid-2009, after the drug was held up for approval in December for that indication.
Medicis expects to launch Dysport in the U.S. as an anti-wrinkle treatment within the next 30 to 60 days, while Ipsen expects to launch Dysport for cervical dystonia during the second half of the year.
The labelling for Dysport contains a boxed warning about the potential risks associated with botulinum toxin products.
"Initially, this warning will likely be unique to Dysport; however, we would not be surprised if Botox received a similar warning in the future," Mann said. Continued...



